Table 3.
Process performance and product quality comparison of calcium phosphate precipitation process upon scale‐up from 1 mL to 1000 mL using Molecule 1 load i and from 1 mL to 2500 mL using Molecule 1 load ii calcium phosphate precipitation condition: 15 mM calcium chloride, 20 mM sodium phosphate
| Load | Working Volume (mL) | Load Purity (% Mon, % agg) | Monomer Yield (%) | Product Purity (% Mon, % agg) |
|---|---|---|---|---|
| i | 1 | 88.0, 12.0 | 89 | 96.0; 4.0 |
| 1 | 89 | 96.5; 3.5 | ||
| 1000 | 81 | 96.7; 3.3 | ||
| 1000 | 85 | 96.6; 3.4 | ||
| ii | 1 | 91.4, 8.6 | 88 | 96.7; 3.3 |
| 1 | 87 | 97.1; 2.9 | ||
| 2500 | 86 | 96.6; 3.4 | ||
| 2500 | 88 | 96.1; 3.9 |